Ibuprofen, an anti-inflammatory, analgesic, and anti-pyretic agent, is a member of a group of drugs known as non-steroidal anti-inflammatory drugs (NSAIDs). Past formulations of ibuprofen have chiefly made use of the water-based form (salt form) of ibuprofen. Ibuprofen in its salt form forms the basis of such drug products as Advil® (potassium salt form of ibuprofen). Use of ibuprofen in its free acid form has been limited to formulations intended for oral administration, e.g., Motrin® in tablet and oral suspension. IBU® Ibuprofen Tablets USP (Knoll Laboratories, Mount Olive, N.J.) is supplied in tablets for oral administration.
NSAIDs are highly effective in treating pain and inflammation in joints, muscles and soft tissue, and are generally given orally for a systemic effect. However, some individuals are unable to tolerate oral intake of ibuprofen. For example, ingestion may result in vomiting, thus leading to ineffective dosing. Others are able to ingest ibuprofen but, as a result, develop gastric mucosal lesions. These lesions lead to gastric discomfort and abdominal pain.